Evaluating the Impact of Vitamin D Supplementation on Healing Bed Sores in ICU.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Maha Salah Dr., lecturer
- Telefonnummer: +201007269331
- E-post: mahata5deer@gmail.com
Studiesteder
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Cairo, Egypt
- Rekruttering
- Ain Shams University
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Ta kontakt med:
- Maha Salah Dr., lecturer
- Telefonnummer: +201007269331
- E-post: mahata5deer@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
inclusion criteria:
1-Critically ill patients with bed sores Grade (1-2), (non-light) exudate admitted to ICUs.
2- Serum vitamin D <20 ng/mL. 3- Both genders. 4- Age: 18-60 years. 5- enteral access in place to enable delivery of vitamin D3 and are deemed to be able to tolerate enteral drug administration.
6- GCS > 9. 7- Serum Calcium (8-10 mg/dl). 8- Serum creatinine less than 1.4 mg/dL. exclusion criteria:
- Refusal of the legal guardian of the patient to participate in the study.
- Current pregnancy or lactating mother.
- Patients who are terminally ill and expected to die in less than 72 hours.
- Renal dysfunction (GFR < 30 mL/min) and the onset of dialysis during the study.
- Vitamin D supplementation in the last 15 days.
- Hypo/hyper-calcemia (adjusted calcium less than 8 mg/dL or above 10).
- History of disorders associated with hypercalcemia (history of cancer with history of hypercalcemia within the past 1 year, hyperparathyroidism, sarcoidosis, nephrolithiasis).
- History of parathyroid dysfunction.
- Ongoing shock, [defined as unstable blood pressure despite vasopressor support and mean arterial pressure (MAP) < 60 mm Hg on at least 3 consecutive readings within a 3-hour period prior to study entry].
- History of malabsorption syndromes; gastrointestinal intolerance (diarrhea, vomiting, or increased nasogastric aspirates).
11. History of adverse reaction to vitamin D supplementation. 12. known history of cirrhosis. 13. Patients taking any medications that have serious drug interactions with vitamin D like statins, orlistat, aluminum hydroxide (interfere with the absorption of vitamin D), digoxin (can enhance the effects of vitamin D on the heart leading to potential toxicity), and certain diuretics (can cause high calcium levels).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Group A (Intervention group)
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50000 I.U. of vitamin d3 dissolved in 45 mL of milk daily for 5 consecutive days (total dose of 250,000 I.U.)
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Ingen inngripen: Group B (Control Group)
No exogenous Vitamin D will be taken.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Pressure Ulcer Healing From Baseline to Day 7, Assessed Using the Pressure Ulcer Scale for Healing (PUSH) Tool
Tidsramme: Baseline (Day 0) to Day 7 after initiation of the study intervention.
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Pressure ulcer healing will be assessed using the Pressure Ulcer Scale for Healing (PUSH). The PUSH tool evaluates wound healing based on wound length × width (surface area), wound exudate amount, and tissue type. A total PUSH score is calculated, with lower scores indicating better healing. The change in PUSH score from baseline to Day 7 will be used to evaluate improvement in pressure-ulcer healing. Calculation: Change in PUSH score = PUSH score at Day 7 - PUSH score at baseline A negative change indicates improvement/healing, whereas a positive change indicates deterioration. |
Baseline (Day 0) to Day 7 after initiation of the study intervention.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Mean Change in Plasma 25-Hydroxyvitamin D [25(OH)D] Concentration From Baseline to Day 7
Tidsramme: Baseline (Day 0) to Day 7 - approximately 7 days after initiation/administration of the study intervention.
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The mean change in plasma 25(OH)D concentration from baseline (Day 0, before administration of the study intervention) to Day 7. The change is calculated as: Change = 25(OH)D concentration at Day 7 - 25(OH)D concentration at baseline The outcome is generally reported in ng/mL (or nmol/L). A positive change indicates an increase in vitamin D concentration, while a negative change indicates a decrease. |
Baseline (Day 0) to Day 7 - approximately 7 days after initiation/administration of the study intervention.
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FMASU MS 434/2025
Plan for individuelle deltakerdata (IPD)
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